1. Field of the Invention
The present invention relates to medical devices for suturing incisions and, more particularly, to a non-disposable trocar needle for suturing laparoscopic incisions and other small incisions. The preferred embodiment of the present invention incorporates both a handle and a curved needle tip which allow a surgeon, with a single twist of the wrist, to pass the needle through the fascia, muscle and peritoneal layers on both sides of an incision.
2. Description of the Related Art
Minimally invasive surgical procedures, such as laparoscopy, are performed through small incisions with specially-designed elongated surgical instruments. Such surgeries typically require puncturing through a patient's body tissue and inserting a hollow cylindrical tube, known as a cannula or sheath, through the puncture. Once the cannula is inserted, the elongated surgical instruments are then manipulated through the cannula.
Following such a procedure, the surgeon must suture the incision closed. This is often a difficult task because such incisions are typically small but deep. For example, a laparoscopic incision through the abdominal wall can be as small as four millimeters (less than one quarter of an inch) in diameter but more than twenty-five millimeters (one inch) deep. Thus, a surgeon typically is unable to get his fingers into the incision to suture in a conventional manner. Instead, a surgeon must typically pass a needle and suture through the tissue on one side of the incision and into the patients body; manipulate the needle and suture with dolphin forceps via the small incision; and then pass the needle and suture through the tissue on the other side of the incision and out of the body. Even though suturing done in this manner is difficult and time consuming, it is important that it be done well. Otherwise, the risk of a hernia through the site of the incision is increased.
Several devices have been developed for suturing incisions. U.S. Pat. No. 4,527,564, issued to Eguchi et al., U.S. Pat. No. 5,059,207, issued to Shah, U.S. Pat. No. 5,320,632, issued to Heidmueller, U.S. Pat. No. 5,336,239, issued to Gimpelson, and U.S. Pat. No. 5,632,752, issued to Buelna, show representative devices. Each of the needles or devices taught by these patents, however, has at least one drawback. Specifically, the needles taught by Eguchi et al., Shah and Gimpelson do not have a handle, or at least a handle that is easily grasped, and therefore each of these needles is difficult to grip and manipulate. Additionally, due to the shapes and sizes of the needles, it is difficult for a surgeon to pass the needles through both sides of an incision in one motion. Likewise the device taught by Buelna, which consists essentially of a handle with a retractable u-shaped needle that curves in the plane of the handle, cannot be passed through both sides of an incision in one motion. Furthermore, both Buelna and Heidmueller teach devices with moving parts which makes sterilization of the instruments more difficult, makes manufacture of the instrument more expensive, and makes use of the instruments more complex.
Additionally, U.S. Pat. No. 5,152,769 to Baber teaches a laparoscopic suturing device for suturing internal incisions. The device consists of an outer barrel and an inner barrel which are inserted through a cannula. A hollowed curved needle is attached to the outer barrel and an open loop grasping means is attached to the inner barrel. The needle and grasping means are manipulated to suture an internal incision such as one of an internal organ within the abdominal cavity.
Similar to the present invention, Baber teaches a needle that is curved in an arc and is perpendicular to its point of attachment. However, Baber differs in its complexity and structure from the present invention. Baber teaches a hollowed needle that is attached to a cylindrical barrel with a suture material fed through the barrel, into the hollowed needle and out of a single opening on the interior aspect of the needle. On the other hand, the present invention teaches a simple and easy-to-use device consisting of a solid needle with a transverse eyelet and an elongated shaft that is attached to an easily grasped knurled handle. Furthermore, in addition to its structural differences from the present invention, the device taught by the Baber patent is designed for use through a cannula and, therefore, is not suited for closing an incision of the outer layers.
As described in the article “Port-Site Closure:A New Problem, An Old Device”, Di Lorenzo et al., JSLS 6 (2):181–183, published April, 2002, a device known as a Deschamps needle has been used for “en masse” ligature of pedicles, and consists of a needle with a curved tip and a handle attached to the shaft of the needle. Although the Deschamps needle bears some resemblance to the present invention, its differences are significant. First, the tip of the Deschamps needle curves extends in a helical curve from the shaft, so that the entrance hole and the exit hole are offset from each other for diagonal stitching, which makes the device unsuitable for small laparoscopic incisions, which may be only one quarter of an inch in length. In contrast, the tip of the present invention curves in a single plane that is perpendicular to the shaft thereby allowing suturing by simply rotating the handle. Importantly, minimizing the required movement of a surgical instrument enhances its ease-of-use and reduces the likelihood of error. The second difference is that the arc of the Deschamps tip is shallow and therefore only allows the tip to pass through a thin layer of tissue. By contrast, the arc of the present invention is deep thereby allowing the surgeon to pass the tip and suture through multiple layers of tissue on both sides of an incision, including relatively thick layers of fascia and muscle. This is significant because increasing the amount of tissue within the suture reduces the risk of hernia.
Consequently, none of the above inventions and patents, taken either singularly or in combination, is seen to describe the instant invention as claimed. Thus a non-disposable trocar needle with a handle solving the aforementioned problems is desired.